Standard Operating Procedure for Temperature Mapping and Monitoring

Purpose

The purpose of this SOP is to establish procedures for conducting temperature mapping studies and monitoring temperature conditions in storage areas to ensure compliance with Good Distribution Practice (GDP) guidelines and maintain product quality.

Scope

This SOP applies to all personnel involved in the planning, execution, and documentation of temperature mapping studies and ongoing temperature monitoring activities.

Responsibilities

• The Quality Assurance (QA) Department is responsible for coordinating and overseeing temperature mapping studies and monitoring activities.
• The Warehouse Management Team is responsible for providing access to storage areas and supporting temperature mapping activities.
• The Facilities Management Team is responsible for maintaining temperature monitoring devices and ensuring their proper functioning.

Procedure

1. Temperature Mapping Planning:
   • Identify storage areas or chambers requiring temperature mapping based on product characteristics, regulatory requirements, and risk assessment.
   • Develop a temperature mapping protocol outlining study objectives, methodology, acceptance criteria, and data analysis plan.
2. Temperature Mapping Execution:
   • Place temperature sensors or data loggers at predetermined locations within the storage area to capture temperature variations.
   • Initiate temperature mapping studies under representative load and environmental conditions, including worst-case scenarios.
3. Data Collection and Analysis:
   • Collect temperature data at specified intervals over the duration of the mapping study.
   • Analyze temperature data to assess temperature distribution, uniformity, and stability within the storage area.
4. Acceptance Criteria:
   • Evaluate temperature mapping results against predefined acceptance criteria, considering regulatory requirements and product stability requirements.
   • Identify any temperature excursions or areas of concern requiring corrective actions.
5. Documentation and Reporting:
   • Prepare a comprehensive report summarizing temperature mapping study procedures, results, and conclusions.
   • Document any deviations from acceptance criteria and the actions taken to address them.
6. Ongoing Temperature Monitoring:
   • Implement a routine temperature monitoring program for all storage areas, including regular checks and recording of temperature data.
   • Calibrate temperature monitoring devices according to established schedules and procedures.

Abbreviations

• QA – Quality Assurance
• GDP – Good Distribution Practice

Documents

Reference documents related to temperature mapping and monitoring may include:

• Temperature mapping protocol
• Temperature mapping report
• Temperature monitoring logs
• Calibration certificates

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0